Impact of COVID-19 Infection on Pancreato-Biliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography.

BACKGROUND: Viral infections are known to impact the pancreato-biliary system; however, there are limited data showing that the same is true of COVID-19. Endoscopic retrograde cholangiopancreatography (ERCP) can safely be performed in patients with COVID-19 infection, but outcomes of patients with COVID-19 infections and concomitant pancreatic and biliary disease requiring endoscopic intervention are unknown. AIMS: This study aims to evaluate the severity of pancreaticobiliary diseases and post-ERCP outcomes in COVID-19 patients. METHODS: Patients with pancreato-biliary disease that required inpatient ERCP from five centers in the United States and South America between January 1, 2020, and October 31, 2020 were included. A representative cohort of patients from each month were randomly selected from each site. Disease severity and post-ERCP outcomes were compared between COVID-19 positive and COVID-19 negative patients. RESULTS: A total of 175 patients were included: 95 COVID positive and 80 COVID negative. Mean CTSI score for the patients who had pancreatitis was higher in COVID-positive cohort by 3.2 points (p < .00001). The COVID-positive group had more cases with severe disease (n = 41) versus the COVID-negative group (n = 2) (p < .00001). Mortality was higher in the COVID-19 positive group (19%) compared to COVID-negative group (7.5%) even though the COVID-19-negative group had higher incidence of malignancy (n = 17, 21% vs n = 7, 7.3%) (p = 0.0455). CONCLUSIONS: This study shows that patients with COVID infection have more severe pancreato-biliary disease and worse post-ERCP outcomes, including longer length of stay and higher mortality rate. These are important considerations when planning for endoscopic intervention. CLINICALTRIALS: gov: (NCT05051358).

EUS-guided Gastroenterostomy: A Multicenter International Study Comparing Benign and Malignant Diseases.

BACKGROUND: Endoscopic ultrasound (EUS)-guided gastroenterostomy (EUS-GE) is a minimally invasive therapy for patients with gastric outlet obstruction without the risks of surgical bypass and the limited long-term efficacy of enteral self-expanding metal stent placement. However, due to its novelty, there is a lack of significant data comparing long-term outcomes of patients with EUS-GE, based on the underlying disease. In this study, we compare outcomes of EUS-GE on benign versus malignant indications. METHODS: Consecutive patients from 12 international, tertiary care centers who underwent EUS-GE over 3 years were extracted in a retrospective registry. Demographic characteristics, procedure-related information and follow-up data was collected. Primary outcome was the rate of adverse events associated with EUS-GE and the comparison of the rate of adverse events in benign versus malignant diseases. Secondary outcomes included technical and clinical success as well as hospitalization admission. RESULTS: A total of 103 patients were included: 72 malignant and 31 benign. The characteristics of the patients undergoing EUS-GE is shown in Table 1. The mean age of the cohort was 68 years and 58 years for malignant and benign etiology. Gender distribution was 57% and 39% being females in malignant and benign etiology group, respectively. Clinical success, technical success, average procedure time, and hospital length of stay were similar in both groups. Patients with benign underlying etiology had significantly higher number of surgically altered midgut anatomy (P=0.0379). CONCLUSION: EUS-GE is equally efficient regardless of the underlying etiology (malignant vs. benign), and the adverse events both groups were comparable.

Endoscopic ultrasound-directed transgastric ERCP (EDGE): A multicenter US study on long-term follow-up and fistula closure.

Background and study aims Endoscopic ultrasound-directed transgastric ERCP (EDGE) is a safe and efficacious procedure to treat pancreaticobiliary diseases in Roux-en-Y gastric bypass (RYGB). This multicenter study aimed to determine the long-term outcomes of EDGE focusing on fistula persistence rates and post-procedure weight change. Patients and methods Information about patients with Roux-en-Y gastric bypass anatomy who underwent EDGE between 2015 and 2021 from 10 institutions was captured in a registry. Patient demographics, procedural details, and clinical outcomes were analyzed. Results One hundred seventy-two patients were included in the study (mean age 60, 25 % male). Technical success of lumen-apposing metal stent (LAMS) placement was 171 of 172 (99.4 %) while clinical success of intervention was 95%. The mean procedure time was 65 minutes. The most commonly reported complication was stent dislodgement/migration (n = 29, 17). Mean length of time of LAMS duration was 69 days. Mean follow-up time was 6 months. Endoscopic fistula closure was performed in 40 % of patients (69/172) at the time of LAMS removal. Persistence of fistula was observed in 19 of 62 patients (31 %) assessed. Length of LAMS indwell time (days) was a predictor of persistent fistula. The average weight gain while the LAMS was in place was 12 lb in 63 patients (36.6 %); 59.4 % of patients gained < 5 lb. Conclusions EDGE is a safe and efficacious procedure for RYGB patients requiring ERCP. Post-procedure evaluation and management of the enteral fistula varies widely among centers currently and would benefit from further standardization. Fistula persistence appears to be uncommon and can be managed endoscopically but may be related to length of indwell times of the LAMS.

Endoscopic Ultrasound-Guided Gallbladder Drainage Versus Percutaneous Drainage in Patients With Acute Cholecystitis Undergoing Elective Cholecystectomy.

INTRODUCTION: Cholecystectomy (CCY) is the gold standard treatment of acute cholecystitis (AC). Nonsurgical management of AC includes percutaneous transhepatic gallbladder drainage (PT-GBD) and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD). This study aims to compare outcomes of patients who undergo CCY after having received EUS-GBD vs PT-GBD. METHODS: A multicenter international study was conducted in patients with AC who underwent EUS-GBD or PT-GBD, followed by an attempted CCY, between January 2018 and October 2021. Demographics, clinical characteristics, procedural details, postprocedure outcomes, and surgical details and outcomes were compared. RESULTS: One hundred thirty-nine patients were included: EUS-GBD in 46 patients (27% male, mean age 74 years) and PT-GBD in 93 patients (50% male, mean age 72 years). Surgical technical success was not significantly different between the 2 groups. In the EUS-GBD group, there was decreased operative time (84.2 vs 165.4 minutes, P < 0.00001), time to symptom resolution (4.2 vs 6.3 days, P = 0.005), and length of stay (5.4 vs 12.3 days, P = 0.001) compared with the PT-GBD group. There was no difference in the rate of conversion from laparoscopic to open CCY: 5 of 46 (11%) in the EUS-GBD arm and 18 of 93 (19%) in the PT-GBD group ( P value 0.2324). DISCUSSION: Patients who received EUS-GBD had a significantly shorter interval between gallbladder drainage and CCY, shorter surgical procedure times, and shorter length of stay for the CCY compared with those who received PT-GBD. EUS-GBD should be considered an acceptable modality for gallbladder drainage and should not preclude patients from eventual CCY.

Invasive CO 2 monitoring with arterial line compared to end tidal CO 2 during peroral endoscopic myotomy.

Background and study aims Peroral endoscopic myotomy (POEM) has become a recognized treatment for achalasia. The technique requires CO 2 insufflation. It is estimated that the partial pressure of CO 2 (PaCO 2 ) is 2 to 5 mm Hg higher than the end tidal CO 2 (etCO 2 ), and etCO 2 is used as a surrogate for PaCO 2 because PaCO 2 requires an arterial line. However, no study has compared invasive and noninvasive CO 2 monitoring during POEM. Patients and methods Seventy-one patients who underwent POEM were included in a prospective comparative study. PaCO 2 plus etCO 2 was measured in 32 patients (invasive group) and etCO 2 only in 39 matched patients (noninvasive group). Pearson correlation coefficient (PCC) and Spearman's Rho were used to calculate the correlation between PaCO 2 and ETCO 2 . Results PaCO 2 and ETCO 2 were strongly correlated: PCC R value: 0.8787 P  ≤ 0.00001, Spearman's Rho R value: 0.8775, P  ≤ 0.00001. Within the invasive group, the average difference between PaCO 2 and ETCO 2 was 3.39 mm Hg (median 3, standard deviation 3.5), within the 2- to 5-mm Hg range. The average procedure time (scope in to scope out) was increased 17.7 minutes ( P  = 0.044) and anesthesia duration was 46.3 minutes. Adverse events (AEs) included three hematomas and one nerve injury in the invasive group and one pneumothorax in the noninvasive group. There were no differences in AE rates between the groups (13 % vs 3 % P  = 0.24). Conclusions Universal PaCO 2 monitoring contributes to increased procedure and anesthesia times without any decrease in AEs in patients undergoing POEM. CO 2 monitoring with an arterial line should only be performed in patients with major cardiovascular comorbidities; in all other patients, ETCO 2 is an appropriate tool.

Drainage Approach for Malignant Biliary Obstruction: A Changing Paradigm.

Endoscopic retrograde cholangiopancreatography (ERCP) is the standard of care in the management of unresectable malignant biliary obstruction. However, endoscopic ultrasound (EUS)-guided biliary drainage has become widely accepted over the past several years for complicated biliary drainage in cases when ERCP is unsuccessful or not feasible. Recent emerging evidence suggests EUS-guided hepaticogastrostomy and EUS-guided choledochoduodenostomy are noninferior, and possibly even superior to conventional ERCP for primary palliation of malignant biliary obstruction. This article reviews the procedural techniques and considerations of the different techniques as well as comparative literature on safety and efficacy between techniques.

Percutaneous endoscopic necrosectomy (PEN) for treatment of necrotizing pancreatitis: a systematic review and meta-analysis.

Background and study aims Endoscopic necrosectomy is limited by the proximity of necrosis to the gastrointestinal tract. Percutaneous endoscopic necrosectomy (PEN) is a minimally invasive endoscopic method of percutaneous debridement. Studies regarding its efficacy and safety are lacking. The purpose of this study was to assess the efficacy and safety of PEN in necrotizing pancreatitis. Methods Pubmed, Ovid, Cochrane, Scopus and Web of Science Database were searched from inception through February 2021. Dual extraction and quality assessment of studies using Cochrane risk of bias tool were performed independently by two authors. The primary outcome was defined as clinical success of PEN. Secondary outcomes included periprocedural morbidity, mortality, and long-term morbidity and mortality. Results Sixteen observational studies including 282 subjects were analyzed. The average reported age of the participants was 50.3 years. Patients with reported gender included 39 % females and 61 % males. The success rate as defined by complete resolution of necrosis and removal of drainage catheters/stents was 82 % (95 % confidence interval 77-87). The mean size of pancreatic necrosis was 14.86 cm (5-54 cm). The periprocedural morbidity rate was 10 %, while there was no reported periprocedural mortality. The long-term morbidity rate was reported as 23 % and mortality at follow-up was 16 %. Conclusions PEN is a novel method of endoscopic management of pancreatic necrosis. Based on our meta-analysis of retrospective studies, it represents a safe treatment modality with high rates of clinical success and low rates of perioperative morbidity and mortality. This study supports the use of PEN when conventional endoscopic therapy is not feasible.

EUS-Guided Biliary Drainage Versus ERCP in Malignant Biliary Obstruction Before Hepatobiliary Surgery: An International Multicenter Comparative Study.

INTRODUCTION: Endoscopic ultrasound-guided biliary drainage (EUS-BD) is the procedure of choice for patients who cannot undergo endoscopic retrograde cholangiopancreatography (ERCP). The outcomes of patients undergoing surgery after EUS-BD for malignancy are unknown. METHODS: We conducted an international, multicenter retrospective comparative study of patients who underwent hepatobiliary surgery after having undergone EUS-BD or ERCP from 6 tertiary care centers. Patient demographics, procedural data, and follow-up care were collected in a registry. RESULTS: One hundred forty-five patients were included: EUS-BD n=58 (mean age 66, 45% male), ERCP n=87 (mean age 68, 53% male). The majority of patients had pancreatic cancer, cholangiocarcinoma, or gallbladder malignancy. In the EUS-BD group, 29 patients had hepaticogastrostomy, 24 had choledochoduodenostomy, and 5 had rendezvous technique done. The most common surgery was Whipple in both groups (n=41 EUS-BD, n=56 ERCP) followed by partial hepatectomy (n=7 EUS-BD, n=14 ERCP) and cholecystectomy (n=2 EUS-BD, n=2 ERCP). Endoscopy clinical success was comparable in both groups (98% EUS-BD, 94% ERCP). Adverse event rates were similar in both groups: EUS-BD (n=10, 17%) and ERCP (n=23, 26%). Surgery technical success and clinical success were significantly higher in the EUS-BD group compared with the ERCP group (97% vs. 83%, 97% vs. 75%). Total Hospital stay from surgery to discharge was significantly higher in the ERCP group (19 d vs. 10 d, P =0.0082). DISCUSSION: Undergoing EUS-BD versus ERCP before hepatobiliary surgery is associated with fewer repeat endoscopic interventions, shorter duration between endoscopy and surgical intervention, higher rates of surgical clinical success, and shorter length of hospital stay after surgery.

Endoscopic Ultrasound-Directed Transgastric ERCP (EDGE) Utilization of Trends Among Interventional Endoscopists.

BACKGROUND: Endoscopic ultrasound-directed transgastric ERCP (EDGE) has become standard-of-care therapy at many centers for pancreaticobiliary disease in patients with Roux-en-Y Gastric Bypass. In this study, we aimed to evaluate the opinions and practices of endoscopists who perform EDGE. METHODS: A 22-question utilization of EDGE survey was sent to 36 advanced endoscopists at tertiary care centers in the United States. The two-section survey included questions regarding advanced endoscopy volume and training at the respective facilities, and questions on specific details of EDGE utilization. RESULTS: Among 36 interventional endoscopists (IE) surveyed, 14 (39%) reported performing > 1000 ERCPs annually. Thirty (83%) offered EDGE as an option for Roux-en-Y gastric bypass patients with previous cholecystectomy. Other options offered included: 19 (53%) offered Laparoscopy-assisted ERCP (LA-ERCP), 7 (19%) offered Single-Balloon ERCP (SBE), and 10 (28%) offered percutaneous drainage (PTC). Twenty (56%) IE performed 10 or less EDGE procedures, while 16 (44%) performed 11 or more. Single-session EDGE was performed by 7 (19%) IE, while 15 (42%) performed dual session, and 13 (36%) performed both. 19 (53%) actively closed fistulas while 17 (47%) let them close spontaneously. Thirty one (86%) reported a technical success rate of 91% to 100%. The most frequently reported immediate adverse event post-procedurally was abdominal pain, reported by 17 IE (47%). Weight gain was reported by 2 IE (6%). CONCLUSION: EDGE continues to gain in popularity as an option for Roux-en-Y gastric bypass patients requiring pancreaticobiliary interventions, with 24/36 IE (67%) believing that it should be the new standard. In addition, most report a low frequency of post-procedural weight gain. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT05041608.

Endoscopic Submucosal Dissection (ESD) Offers a Safer and More Cost-effective Alternative to Transanal Endoscopic Microsurgery (TEM): An International Collaborative Study.

BACKGROUND: Endoscopic submucosal dissection (ESD) and transanal endoscopic microsurgery (TEM) are minimally invasive procedures that treat early rectal cancer (ERC). Both are effective treatments, yet there are very few studies comparing them. The aim of our study was to identify ideal candidates for each procedure. MATERIALS AND METHODS: Between January 2016 and November 2019, 204 ERC patients were managed with either ESD (n=101) or TEM (n=103) at 7 international centers. Data analyzed included clinical success, tumor characteristics, procedure info, and recurrence rates. RESULTS: Median tumor size was 40 mm±23.9 in the ESD group and 56 mm±27.9 in the TEM group, significantly larger in the latter ( P <0.00001). Average procedure time was 131.5±67.9 minutes in ESD group and 104.9±28.4 minutes in TEM group ( P =0.000347). Average hospital stay was 3.3±2.6 days in the ESD group and 4.7±0.7 days in the TEM group ( P <0.00001). Adverse event rate was 6.8% in the ESD group and 24% in the TEM group. There were no significant difference in the rate of en bloc resection, technical success, tumor location, necessity of additional procedures, and tumor recurrence rates. CONCLUSION: Compared with TEM, ESD is a safer procedure with shorter hospital stay and should be offered for patients who have ERC.

Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study.

INTRODUCTION: Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States. METHODS: We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected. RESULTS: A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs. CONCLUSIONS: The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.

Subepithelial tumors: How does endoscopic full-thickness resection & submucosal tunneling with endoscopic resection compare with laparoscopic endoscopic cooperative surgery?

Background and study aims Endoscopic techniques are rapidly emerging for resection of subepithelial tumors (SETs). Submucosal tunneling for endoscopic resection (STER), endoscopic full-thickness resection (EFTR) and laparoscopic endoscopic cooperative surgery (LECS) are current alternatives to open surgery. In this study, we aimed to compare the three endoscopic techniques. Patients and methods Consecutive patients who underwent resection of a submucosal esophageal or gastric lesion at several tertiary care centers were included in a dedicated registry over 3 years. Demographics, size and location of resected lesion, histology of specimen, length of procedure, adverse events (AEs), duration of hospital stay, and follow-up data were collected. Results Ninety-six patients were included (47.7 % male, mean age 62): STER n = 34, EFTR n = 34, LECS n = 280. The lesions included leiomyoma, gastrointestinal stromal tumors (GISTs) and other. The mean lesion size was 28 mm (STD 16, range 20-72 mm). The majority of lesions in the EFTR and laparoscopic-assisted resection group were GISTs. There was no significant difference in clear resection margins, post-procedure complication rates, recurrence rate and total follow-up duration between the groups. However, the LECS group had a procedure time at least 30 minutes longer than STER or EFTR ( P  < 0.01). Total hospital stay for the laparoscopic-assisted resection group was also longer when compared to STER (1.5) and EFTR (1.8) ( P  < 0.01). Conclusions STER, EFTR, and laparoscopic-assisted resection are efficacious approaches for resection of SETs with similar R0 resection rates, complication rates, and AE rates. Laparoscopic assisted resection appears more time-consuming and is associated with a longer hospital stay.

First interobserver agreement of optical coherence tomography in the bile duct: A multicenter collaborative study.

Background and study aims Optical coherence tomography (OCT) is a new technology available for evaluation of indeterminate biliary strictures. It allows under-the-surface visualization and preliminary studies have confirmed standardized characteristics associated with malignancy. The aim of this study is to evaluate the first interobserver agreement in identifying previously agreed upon OCT criteria and diagnosing of malignant versus benign disease. Patients and methods Fourteen endoscopists were asked to review an atlas of reference clips and images of eight criteria derived from expert consensus A total of 35 de-identified video clips were then evaluated for presence of the eight criteria and for final diagnosis of malignant versus benign using the atlas as reference Intraclass correlation (ICC) analysis was done to evaluate interrater agreement. Results Clips of 23 malignant lesions and 12 benign lesions were scored. Excellent interobserver agreement was seen with dilated hypo-reflective structures (0.85) and layering effacement (0.89); hyper-glandular mucosa (0.76), intact layering (0.81), and onion-skin layering (0.77); fair agreement was seen with scalloping (0.58), and thickened epithelium (0.4); poor agreement was seen with hyper-reflective surface (0.36). The diagnostic ICC for both neoplastic (0.8) and non-neoplastic (0.8) was excellent interobserver agreement. The overall diagnostic accuracy was 51 %, ranging from 43 % to 60 %. Conclusions Biliary OCT is a promising new modality for evaluation of indeterminate biliary strictures. Interobserver agreement ranged from fair to almost perfect on eight previously identified criteria. Interobserver agreement for malignancy diagnosis was substantial (0.8). Further studies are needed to validate this data.

Safety and efficacy of endoscopic sleeve gastroplasty for obesity management in new bariatric endoscopy programs: a multicenter international study.

Background: Endoscopic sleeve gastroplasty (ESG) is an incisionless procedure that reduces the size of the gastric cavity. In prior studies, it has been proven to be a safe and effective treatment for obesity. In this study, we performed a collaborative study to evaluate the effectiveness of ESG among new endobariatric programs. Methods: This was an international, multicenter study reviewing the outcomes of ESG in centers starting ESG programs. Total body weight loss, change of body mass index (BMI), excess body weight loss (EBWL), technical success, duration of hospitalization, and immediate and delayed adverse events and complications at 24 h, 1 week, and 1, 3, and 6 months post-procedure were evaluated. Results: A total of 91 patients (35 males) from six centers were included. The patients' mean BMI before the procedure was 38.7 kg/m2. BMI reduction at 3 months was 7.3 (p < 0.000), at 6 months 9.3 (p < 0.000), and at 12 months 8.6 (p < 0.000) from baseline. EBWL was 17.3% at 1 month (p < 0.000), 29.2% at 3 months (p < 0.000), and 35.6% at 6 months (p < 0.000). The mean procedure duration was 85.1 min. The mean length of hospital stay post-procedure was 27 h. Conclusion: ESG provides EBWL percentage sustained up to 12 months. These results are equivalent among the new ESG centers compared to previous studies by expert centers. Lay title: Endoscopic sleeve gastroplasty in new bariatric endoscopy programs. Plain Language Summary: This article is the result of a collaborative international study on new endoscopic programs offering endoscopic sleeve gastroplasty.The minimally invasiveness and increasing accessibility of this technique makes it very attractive for patients with obesity while being poor candidate for surgery or refusing surgery.This study will also provide valuable information regarding this rising technique of endobariatric treatment.

Endoscopic or surgical treatment for necrotizing pancreatitis: Comprehensive systematic review and meta-analysis.

Background and study aims Treatment of necrotizing pancreatitis is changed over the past two decades with the availability of endoscopic, and minimally invasive surgical approaches. The aim of this systematic review was to assess outcomes of endoscopic drainage, and different types of surgical drainage approaches in necrotizing pancreatitis. Methods Medline, Embase, Scopus, and Web of Science were searched from 1998 to 2020 to assess outcomes in endoscopic drainage and various surgical drainage procedures. The assessed variables consisted of mortality, development of pancreatic or enteric fistula, new onset diabetes mellitus, and exocrine pancreatic insufficiency. Results One hundred seventy studies comprising 11,807 patients were included in the final analysis. The pooled mortality rate was 22 % (95 % confidence interval [CI]: 19%-26 %) in the open surgery (OS), 8 % (95 %CI:5 %-11 %) in minimally invasive surgery (MIS), 13 % (95 %CI: 9 %-18 %) in step-up approach, and 3 % (95 %CI:2 %-4 %) in the endoscopic drainage (ED). The pooled rate of fistula formation was 35 % (95 %CI:28 %-41 %) in the OS, 17 % (95 %CI: 12%-23 %) in MIS, 17 % (95 %CI: 9 %-27 %) in step-up approach, and 2 % (95 %CI: 0 %-4 %) in ED. There were 17 comparative studies comparing various surgical drainage methods with ED. The mortality rate was significantly lower in ED compared to OS (risk ratio [RR]: 30; 95 %CI: 0.20-0.45), and compared to MIS (RR: 0.40; 95 %CI: 0.26-0.6). Also, the rate of fistula formation was lower in ED compared to all other surgical drainage approaches. Conclusions This systematic review demonstrated lower rate of fistula formation with ED compared to various surgical drainage methods. A lower rate of mortality with ED was also observed in observational studies. PROSPERO Identifier: CRD42020139354.

Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial.

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis (WOPN) lacks dedicated instruments and requires repetitive and cumbersome procedures. This study evaluated the safety and efficacy of a new powered endoscopic debridement (PED) system designed to simultaneously resect and remove solid debris within WOPN. METHODS: This was a single-arm, prospective, multicenter, international device trial conducted from November 2018 to August 2019 at 10 sites. Patients with WOPN ≥6 cm and ≤22 cm and with >30% solid debris were enrolled. The primary endpoint was safety through 21 days after the last DEN procedure. Efficacy outcomes included clearance of necrosis, procedural time, adequacy of debridement, number of procedures until resolution, hospital stay duration, and quality of life. RESULTS: Thirty patients (mean age, 55 years; 60% men) underwent DEN with no device-related adverse events. Of 30 patients, 15 (50%) achieved complete debridement in 1 session and 20 (67%) achieved complete debridement within 2 or fewer sessions. A median of 1.5 interventions (range, 1-7) were required. Median hospital stay was 10 days (interquartile range, 22). There was an overall reduction of 91% in percent necrosis within WOPN from baseline to follow-up and 85% in collection volume. Baseline WOPN volume was positively correlated with the total number of interventions (ρ = .363, P = .049). CONCLUSIONS: The new PED system seems to be a safe and effective treatment tool for WOPN, resulting in fewer interventions and lower hospital duration when compared with published data on using conventional instruments. Randomized controlled trials comparing the PED system with conventional DEN are needed. (Clinical trial registration number: NCT03694210.).

Hepaticogastrostomy versus choledochoduodenostomy: An international multicenter study on their long-term patency.

BACKGROUND AND OBJECTIVES: EUS-guided biliary drainage (EUS-BD) offers minimally invasive decompression when conventional endoscopic retrograde cholangiopancreatography fails. Stents can be placed from the intrahepatic ducts into the stomach (hepaticogastrostomy [HG]) or from the extrahepatic bile duct into the small intestine (choledochoduodenostomy [CCD]). Long-term patency of these stents is unknown. In this study, we aim to compare long-term patency of CCD versus HG. METHODS: Consecutive patients from 12 centers were included in a registry over 14 years. Demographics, procedure info, adverse events, and follow-up data were collected. Student's t-test, Chi-square, and logistic regression analyses were conducted. Only patients with at least 6-month follow-up or who died within 6-month postprocedure were included. RESULTS: One-hundred and eighty-two patients were included (93% male; mean age: 70; HG n = 95, CCD n = 87). No significant difference in indication, diagnosis, dissection instrument, or stent type was seen between the two groups. Technical success was 92% in both groups. Clinical success was achieved in 75/87 (86%) in the HG group and 80/80 (100%) in the CCD group. A trend toward higher adverse events was seen in the CCD group. A total of 25 patients out of 87 needed stent revision in the HG group (success rate 71%), while eight out of 80 were revised in the CCD group (success rate 90%). Chi square shows CCD success higher than HG (90% vs. 71%, P = 0.010). After adjusting for diagnosis, jaundice or cholangitis presentation, instrument used for dissection, and gender, CCD was 4.5 times more likely than HG to achieve longer stent patency or manage obstruction (odds ratio 4.5; 95% 1.1548-17.6500, P = 0.0302). CONCLUSION: CCD is associated with superior long-term patency than HG but with a trend toward higher adverse events. This is particularly important in patients with increased survival. Additional studies are required before recommending a change in practice.

Digital single-operator cholangioscopy interobserver study using a new classification: the Mendoza Classification (with video).

BACKGROUND AND AIMS: Digital single-operator cholangioscopy (DSOC) allows direct visualization of the biliary tree for evaluation of biliary strictures. Our objective was to assess the interobserver agreement (IOA) of DSOC interpretation for indeterminate biliary strictures using newly refined criteria. METHODS: Fourteen endoscopists were asked to review an atlas of reference clips and images of 5 criteria derived from expert consensus. They then proceeded to score 50 deidentified DSOC video clips based on the visualization of tortuous and dilated vessels, irregular nodulations, raised intraductal lesions, irregular surface with or without ulcerations, and friability. The endoscopists then diagnosed the clips as neoplastic or non-neoplastic. Intraclass correlation (ICC) analysis was done to evaluate inter-rater agreement for both criteria sets and final diagnosis. RESULTS: Clips of 41 malignant lesions and 9 benign lesions were scored. Three of 5 revised criteria had almost perfect agreement. ICC was almost perfect for presence of tortuous and dilated vessels (.86), raised intraductal lesions (.90), and presence of friability (.83); substantial agreement for presence of irregular nodulations (.71); and moderate agreement for presence of irregular surface with or without ulcerations (.44). The diagnostic ICC was almost perfect for neoplastic (.90) and non-neoplastic (.90) diagnoses. The overall diagnostic accuracy using the revised criteria was 77%, ranging from 64% to 88%. CONCLUSIONS: The IOA and accuracy rate of DSOC using the new Mendoza criteria shows a significant increase of 16% and 20% compared with previous criteria. The reference atlas helps with formal training and may improve diagnostic accuracy. (Clinical trial registration number: NCT02166099.).

Per Oral Endoscopic Myotomy for Zenker's Diverticulum: A Novel and Superior Technique Compared With Septotomy?

INTRODUCTION: Endoscopic management of Zenker diverticuli (ZD) has traditionally been via septotomy technique. The recent development of tunneling technique has shown to be both efficacious and safe. The aim of this study is to evaluate the tunneling technique using per oral endoscopic myotomy (Z-POEM) versus septotomy. METHODS: Patients who underwent endoscopic management of ZD either by Z-POEM or septotomy from March 2017 until November 2020 from 9 international academic centers were included. Demographics, clinical data preprocedure and postprocedure, procedure time, adverse events, and hospital length of stay were analyzed. RESULTS: A total of 101 patients (mean age 74.9 y old, 55.4% male) were included: septotomy (n=49), Z-POEM (n=52). Preprocedure Functional Oral Intake Scale score and Eckardt score was 5.3 and 5.4 for the septotomy group and 5.9 and 5.15 for the Z-POEM group. Technical success was achieved in 98% of the Z-POEM group and 100% of the septotomy group. Clinical success was achieved in 84% and 92% in the septotomy versus Z-POEM groups. Adverse events occurred in 30.6% (n=15) in septotomy group versus 9.6% (n=5) in the Z-POEM group (P=0.017). Reintervention for ongoing symptoms occurred in 7 patients in the septotomy group and 3 patients in the Z-POEM group. Mean hospital length of stay was shorter for the Z-POEM group, at 1.5 versus 1.9 days. CONCLUSIONS: A tunneling technique via the Z-POEM procedure is an efficacious and safe endoscopic treatment for ZD. Z-POEM is a safer procedure with a statistically significant reduction in adverse events compared with traditional septotomy technique.

Digital Cholangioscopic Interpretation: When North Meets the South.

BACKGROUND: Digital single-operator cholangioscopy (DSOC) (SpyGlass DS™, Boston Scientific, MA, USA) allows for high-definition imaging of the biliary tree. The superior visualization has led to the development of two different sets of criteria to evaluate and classify indeterminate biliary strictures: the Monaco criteria and the criteria in Carlos Robles-Medranda's publication (CRM). Our objective was to assess the interrater agreement (IA) of DSOC interpretation for indeterminate biliary strictures using the two newly published criteria. METHODS: Forty de-identified DSOC video recordings were sent to 15 interventional endoscopists with experience in cholangioscopy. They were asked to score the videos based on the presence of Monaco Classification criteria: stricture, lesion, mucosal changes, papillary projections, ulceration, white linear bands or rings, and vessels. Next, they scored the videos using CRM criteria: villous pattern, polypoid pattern, inflammatory pattern, flat pattern, ulcerate pattern and honeycomb pattern. The endoscopists then diagnosed the recordings as neoplastic or non-neoplastic based on the criteria. Intraclass correlation (ICC) analysis was done to evaluate interrater agreement for both criteria set and final diagnosis. RESULTS: Recordings of 26 malignant lesions and 14 benign lesions were scored. The IA using both the Monaco criteria and CRM criteria ranged from poor to excellent (range 0.1-0.76) and (range 0.1-0.62), respectively. Within the Monaco criteria, IA was excellent for lesion (0.75) and fingerlike papillary projections (0.74); good for tortuous vessels (0.7), mucosal features (0.62), uniform papillary projections (0.53), and ulceration (0.58); and fair for white linear bands (0.4). Within the CRM criteria, the IA was good for villous pattern (0.62), flat pattern (0.62), and honeycomb pattern; fair for ulcerated pattern (0.56), polypoid pattern (0.52) and inflammatory pattern (0.54). The diagnostic IA using Monaco criteria was good (0.65), while the diagnostic IA using CRM was fair (0.58). The overall diagnostic accuracy using the Monaco classification was 61% and CRM criteria were 57%. CONCLUSION: The IOA and accuracy rate of DSOC using visual criteria from both Monaco Criteria and CRM are similar. However, some criteria from both sets suffer from poor IA, thus affecting the overall diagnostic accuracy. More formal training and refinements in visual criteria with additional validation are needed to improve diagnostic accuracy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02166099.